Auditing multiple standards - TS 16949, ISO 14001 & OHSAS 18001

Elsmar Forum Sponsor

Paul Simpson

Trusted Information Resource
#12
The 2000 changes to ISO 9001 should encourage integrated auditing. We are supposed to be auditing processes rather that functions. Observing and assessing activities rather than carrying out compliance checks on procedures against documentation.

If the process has elements of quality, environmental and health & safety then we assess these as we go. The clever bits are:
  1. the planning to make sure we pick up all the elements of each of the standards in the relevant areas / processes
  2. the note taking to make sure we juggle the clauses and note tham against activities assessed
  3. reporting to the client - balanced against risk and findings

Previous posts about the difficulty in getting a balanced assessment against all three standards are true.

From my own point of view, like most, I started in quality and then moved into environment and latterly health & safety. Before auditing anyone I would want to be sure of my own competence and that tends to lead to spending more time and effort in training and preparation for the "new" requirements until they become second nature.
 
W

Wayne G.

#13
Thanks to all who replied to this thread. The management at my facility was under the impression that combining audits would save a substantial amount of time. That is not necessarily true. Efficiency, perhaps. Even when combining the basic requirements such as management review, internal auditing, control of records, etc., the auditor needs a sample of the requirement from all standards. Not only to satify the different external auditors, but because of different element or process owners.

Anyone have any input on assessing and presenting risk from these audit results to management? Dollar value is key.

Thanks
 
Thread starter Similar threads Forum Replies Date
K Internal Auditing - Umbrella QMS and Multiple Standards Oil and Gas Industry Standards and Regulations 4
W Auditing to multiple standards & requirements - CMDR, MDD, ISO13485, QSR. General Auditing Discussions 3
E Informational Internal Audits - Wear multiple hats what can and can't I audit (so I'm not auditing my own work) Internal Auditing 149
bio_subbu GHTF - Guidance on QMS Audits at Multiple Sites / Regulatory Auditing Strategy Other Medical Device Related Standards 1
S ISO 9001:2015 Internal Auditing Internal Auditing 8
H Auditing Santa's workshop General Auditing Discussions 0
C List of MDSAP Auditing Organizations Medical Device and FDA Regulations and Standards News 1
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 7
cscalise Suggestions for MDR Auditing tools EU Medical Device Regulations 1
J Auditing of Support Function IATF 16949 - Automotive Quality Systems Standard 9
D ISO 13485, FDA 21 CFR 820 and Auditing the Accounting Department ISO 13485:2016 - Medical Device Quality Management Systems 5
S Risk based internal auditing Internal Auditing 6
Randy Remote auditing (for disaster, disease, disturbance etc...) during the Neo Coronavirus Pandemic and Social Distancing Registrars and Notified Bodies 7
K ANVISA B-GMP Auditing requirements for Contract Manufacturers Other Medical Device Regulations World-Wide 1
F AS9100D Internal auditing requirements Internal Auditing 11
R Does any here use an internal auditing tool that works on different platforms? Internal Auditing 3
W Does anyone have an API Q2 checklist for internal auditing? Oil and Gas Industry Standards and Regulations 1
G Best Practices for IT auditing - Is a session-id necessary for a complete audit trail? IEC 27001 - Information Security Management Systems (ISMS) 0
I Questions to ask when auditing for Organizational Leadership and Planning for the QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 6
blackholequasar Internal Auditing Inspiration - Getting volunteers to perform internal audits. Internal Auditing 22
W Internal Auditing carried out by a 3rd party - Review of previous audits AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
tony s What is the automotive process approach for auditing? IATF 16949 - Automotive Quality Systems Standard 2
S Internal Auditing for API Spec Q1 - auditor qualification requirements Oil and Gas Industry Standards and Regulations 6
R I've been auditing for a CB for 18 years General Auditing Discussions 10
P Consultant Auditing Qualifications Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
M We still have not received our certificate due to a 'backlog' with our auditing body Registrars and Notified Bodies 25
N Online Internal Auditing Course for ISO 13485 - Suggestions ISO 13485:2016 - Medical Device Quality Management Systems 8
A Agenda for 8D audit on Supplier's side - Auditing Corrective Actions General Auditing Discussions 5
U Internal auditing - Company employees or contract second party Internal Auditing 10
J Recomended Values - Auditing process in a supplier IATF 16949 - Automotive Quality Systems Standard 18
M Canada - Registrars that allow e-auditing for ISO 9001? Registrars and Notified Bodies 4
D Auditing Our Outsourced 2nd-3rd Party Internal Audit Company ISO 13485:2016 - Medical Device Quality Management Systems 6
supadrai Auditing Organization dragging their heels on issuing our MDSAP Surveillance Audit Confirmation Letter - everyone is nervous ... are we the only ones? Canada Medical Device Regulations 7
Ed Panek Supplier Auditing - No purchases from our key suppliers in the last 24 months ISO 13485:2016 - Medical Device Quality Management Systems 5
P Auditing "process validation" process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
qualprod Effective Auditing advice needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
M Acceptance of remote auditing techniques - Can you help me with my research? General Auditing Discussions 0
GStough Auditing Against Criteria Unfamiliar to Auditee - Yea or Nay? General Auditing Discussions 11
qualprod Auditing Product and Services doubts ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Auditing support and management processes General Auditing Discussions 7
F It is acceptable moving remote locations staff to manufacturing plant for auditing? IATF 16949 - Automotive Quality Systems Standard 3
D MSDS / GHS Walk-through / Auditing Occupational Health & Safety Management Standards 6
Pmarszal Supplier Auditing Services (Audit Needed?) General Auditing Discussions 4
S ISO 9001 Audit Observations - Transitioning my career into auditing Career and Occupation Discussions 16
G AS9101 Rev F - Worksheets for internal auditing AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
N API Q2 clause 6.2.2.1 Auditing Outsourced Suppliers Oil and Gas Industry Standards and Regulations 5
M Auditing processes followed by employees placed on client's site Internal Auditing 4
S ISO 13485:2016 and MDSAP internal auditing ISO 13485:2016 - Medical Device Quality Management Systems 6
M Auditing a Contractor in EMS and Non Conformity Report General Auditing Discussions 1

Similar threads

Top Bottom